Download Trade Advice Notice on the Product SILIRUM VACCINE, Product

TRADE ADVICE NOTICE
on the Product SILIRUM VACCINE
APVMA Product Number 59642
FEBRUARY 2014
© Australian Pesticides and Veterinary Medicines Authority 2014
ISSN: 2200-3894 (electronic)
ISBN: 978-1-922188-55-7 (electronic)
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Australian Pesticides and Veterinary Medicines Authority
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KINGSTON ACT 2604 Australia
Telephone: +612 6210 4701
Email: [email protected].
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CONTENTS
iii
CONTENTS
PREFACE
IV
Making a submission
iv
Further information
v
1
INTRODUCTION
1
2
TRADE CONSIDERATIONS
2
2.1
Proposed Australian use pattern
2
2.2
Destination and value of exports
2
3
CONCLUSIONS
4
LIST OF TABLES
Table 1:
5 largest export markets by value for live cattle in 2013.
3
iv
TRADE ADVICE NOTICE – SILIRUM VACCINE
PREFACE
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government
regulator with responsibility for assessing and approving agricultural and veterinary chemical products prior
to their sale and use in Australia.
In undertaking this task, the APVMA works in close cooperation with advisory agencies including Department
of Agriculture and Animal Health Committee
The APVMA has a policy of encouraging openness and transparency in its activities and of seeking
stakeholder involvement in decision making. Part of that process is the publication of Trade Advice Notices
where there may be trade implications.
Comment is sought from industry groups and stakeholders on the information contained within this
document.
Making a submission
The APVMA invites any person to submit a relevant written submission as to whether the application to
register the new product SILIRUM VACCINE should be granted. Submissions should relate only to matters
that the APVMA is required, by legislation, to take into account in deciding whether to grant the application.
These matters relate to the implications for export trade of the use of the product. Comments received
outside these matters cannot be considered by the APVMA. Submissions should state the grounds on which
they are based.
Submissions must be received by the APVMA by close of business on Thursday, 6 March 2014 and be
directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email
or by post. Relevant comments will be taken into account by the APVMA in deciding whether to grant the
application and in determining appropriate conditions of registration and product labelling.
When making a submission please include:

contact name

company or group name (if relevant)

email address or postal address (if available)

the date you made the submission.
All personal and confidential commercial information (CCI)1 material contained in submissions will be
treated confidentially.
1
A full definition of "confidential commercial information" is contained in the Agvet Code.
PREFACE
Written submissions on the APVMA’s proposal to grant the application to register the new product SILIRUM
VACCINE that relate to the trade implications for registration should be emailed to the email address
provided below:
Hardcopy submissions (or files on digital media) can be sent to:
Contact Officer
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Phone: +612 6210 4736
Fax:
+612 6210 4741
Email: [email protected]
Further information
Further information on trade advice notices can be found on the APVMA website: www.apvma.gov.au.
v
INTRODUCTION
1
1
INTRODUCTION
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from
Zoetis Australia Pty Ltd, to register the new product SILIRUM VACCINE as an aid in control of Bovine
Johne’s disease (BJD).
Johne's disease or paratuberculosis is a chronic debilitating enteritis of ruminants caused by Mycobacterium
avium subsp. paratuberculosis.
SILIRUM VACCINE for cattle is an inactivated and oil adjuvanted vaccine, indicated for the active
immunisation of cattle against Mycobacterium avium subsp. paratuberculosis, as an aid in the control of
Bovine Johne’s Disease (BJD). It contains 2.5 mg/ml of dried Mycobacterium avium subsp. paratuberculosis
(Map) Strain 316 F.
All major live cattle export countries require individual testing and/or property freedom status for a set time
for BJD.
Data provided by Zoetis has indicated that cattle administered with SILIRUM VACCINE are likely to test
positive when screened for tuberculosis (caudal fold test) or Johne’s disease (blood antibody test) which
might have serious implications on the Australian exports of live cattle.
2
TRADE ADVICE NOTICE – SILIRUM VACCINE
2
TRADE CONSIDERATIONS
Exported live cattle which have been vaccinated with SILIRUM VACCINE may pose a risk to Australia trade
in situations where negative screening test results are required by the importing countries for tuberculosis
(caudal fold test) or Johne’s disease (blood antibody test). All the major live cattle export countries like
Indonesia, Malaysia, Vietnam, China, Japan, Philippines and Russia require individual testing and/or
property freedom status for a set time for of Bovine Johne’s disease (BJD).
Although some countries accept the tuberculosis free status of Australia, some countries like Japan still
require the screening test.
The Animal Health Committee (AHC) has considered the implications of the registration of SILIRUM
VACCINE on Australia’s live export trade and made the following main recommendations.
1. vaccinated animals are excluded from export markets that are sensitive to Johne’s Disease or
bovine tuberculosis unless there is an agreement on the eligibility for export of vaccinated animals
with the importing country and
2.
the vaccinates are positively identified with a unique identifier such as NLIS-style button.
The APVMA has proposed to include the following two label restraint statements to address the trade
concerns:
1.
DO NOT vaccinate cattle intended for live export to countries requiring tuberculosis testing. Cattle
administered with this killed vaccine are likely to test positive when screened for tuberculosis (caudal fold
test) due to cross reactivity between the vaccine and the test.
2.
DO NOT vaccinate cattle intended for live export to countries requiring JD negative antibody testing.
Cattle administered with this killed vaccine may test positive when screened for Johne’s Disease (JD-ELISA blood antibody test) due to immunity developed to the vaccine.
2.1
Proposed Australian use pattern
Live cattle
2.2
Destination and value of exports
The total exports of Australian Live cattle are valued at approximately $340 million.The 5 largest export
markets for Australian live cattle by value are shown below (Australian Commodity Statistics 2013).
RESIDUES IN LIVESTOCK
Live cattle exports in 2012-2013 (Source: ABARE 2013)
Table 1: Five largest export markets by value for live cattle in 2013.
RANK
(BY $
VALUE)
IMPORTING
COUNTRY
1
Indonesia
2
QUANTITY
VALUE
(‘000 OF ANIMALS)
($AUS MILLION)
266.1
164.5
Israel
63.8
45.1
3
Turkey
35.6
23.7
4
Malaysia
36.9
23.1
5
Philippines
35.3
21.5
513.1
338.6
Total
3
4
3
TRADE ADVICE NOTICE – SILIRUM VACCINE
CONCLUSIONS
The APVMA has considered whether the use of SILIRUM VACCINE for cattle in accordance with the
proposed label instructions could “unduly prejudice trade or commerce between Australia and places outside
Australia”, as per Section 14(3)(e)(iv) of the Agvet Code.
The risk to Australia's live cattle export trade could be mitigated when the following proposed label restraint
statements are observed:
1. DO NOT vaccinate cattle intended for live export to countries requiring tuberculosis testing. Cattle
administered with this killed vaccine are likely to test positive when screened for tuberculosis (caudal
fold test) due to cross reactivity between the vaccine and the test.
2. DO NOT vaccinate cattle intended for live export to countries requiring JD negative antibody testing.
Cattle administered with this killed vaccine may test positive when screened for Johne’s Disease
(JD-ELISA - blood antibody test) due to immunity developed to the vaccine
The APVMA is seeking comment from relevant industry groups and stakeholders in relation to the perceived
level of risk to Australia's live cattle export trade.